▶ Regeneron Announces FDA Acceptance of EYLEA (aflibercept) Injection Supplemental Biologics License Application for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion
- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of October 23, 2014.
EYLEA의 경우에는 2012년 기준 바이오 의약품 매출액이 $857 M (약 9천억원, La Marie 2012) 이었다. FDA 승인 이후 바로 다음해에 얻은 실적이나 과히 엄청나다. 2011년에는wet (neovascular) age-related macular degeneration (AMD) 치료를 위해 FDA 승인을 받았다.
지금은 BRVO로 일어나는 MD를 위한 sBLA에 관한 내용이다.
EYLEA는 항체가 아니라 계획화 된 fusion protein이다. Angiogenesis는 VEGFR2를 통하여 진행된다는 것이 정설이지만, EYLEA의 개발에는VEGF와 VEGFR1의 binding affinity 가 VEGF vs. VEGFR2 보다탁월하다는 점에 주목했다. VEGFR1의 VEGF binding site이 두번째 도메인, VEGFR1의 세번째 도메인을 이용하여 fusion protein을 개발하였다. 발표 논문에 따르면 이 fusion protien의 VEGF와의 binding affinity는 Genetech에서 개발한 Fab type인 Lucentis_Ranibizumab 보다도 뛰어나 보인다.
▪The EYLEA sBLA submission in this indication is based on the positive results from the Phase 3 VIBRANT trial, which was a double-masked, randomized, active-controlled study of 183 patients with Macular Edema following Branch Retinal Vein Occlusion. Patients received either intravitreal EYLEA 2 milligrams (mg) every four weeks or laser treatment for 24 weeks. The primary objective of the study was to evaluate the efficacy and safety of EYLEA in improving best-corrected visual acuity compared to laser treatment at week 24. The study is ongoing through week 52.
▪EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the European Union (EU) and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in the U.S. and the EU for EYLEA for the treatment of Diabetic Macular Edema.
▪About Branch Retinal Vein Occlusion
Retinal Vein Occlusion is the second most common retinal vascular disorder and is a significant cause of visual impairment. Of the two main types of retinal vein occlusion - CRVO and BRVO - the latter is more common. In BRVO, a blockage occurs in the blood vessels branching from the main vein draining the retina, resulting in the release of vascular endothelial growth factor and consequent retinal edema.
